Latest news with #ODD
Korea Herald
10-07-2025
- Business
- Korea Herald
IASO Bio Receives Orphan Drug Designation from the Ministry of Food and Drug Safety of South Korea for Equecabtagene Autoleucel
SHANGHAI, NANJING, China and SAN FRANCISCO, July 9, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that its self-developed anti-BCMA CAR-T cell therapy product, Equecabtagene Autoleucel (Fucaso), has been granted Orphan Drug Designation (ODD) by the Ministry of Food and Drug Safety (MFDS) of South Korea for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Currently, the Korean MFDS adopts a dual standard for orphan drug designation: 1. Drugs used for diseases with a domestic patient population (prevalence) of 20,000 or fewer; 2. Drugs used for diseases for which appropriate treatment methods or drugs have not been developed, or drugs that demonstrate significantly improved safety or efficacy compared to existing alternative drugs. For orphan drugs that are "available abroad but not domestically", South Korea has policies to facilitate their import*. Following ODD, the registration and approval process of Equecabtagene Autoleucel Injection in South Korea is expected to be accelerated, potentially enabling earlier access for local patients. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Biotherapeutics, stated: "The Orphan Drug Designation granted to Equecabtagene Autoleucel Injection in South Korea marks another significant international regulatory milestone for the product, following its ODD approval in Saudi Arabia in May. This Designation is expected to accelerate patient access to this CAR-T therapy in South Korea. IASO Bio is implementing its global registration strategy of 'parallel multi-country submissions with regional synergy'to obtain approvals for this innovative cell therapy in additional countries and regions, ultimately extending its benefits to a wider patient population." About Multiple Myeloma（MM) Multiple myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses. About Equecabtagene Autoleucel（Fucaso） Equecabtagene Autoleucel（Fucaso） is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane domain, and 4-1BB co-stimulatory molecule and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve deep and durable remission,providing continuous protection and care for patients with multiple myeloma. About IASO Bio IASO Bio is a biopharmaceutical company focused on the discovery and development of innovative cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization. Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022. Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit or
Yahoo
07-06-2025
- Business
- Yahoo
Online Cosmetics Retailer Oddity Draws in Big Money
ODD is an online cosmetics retailer offering its more than 60 million users an AI platform to shop and buy customized cosmetics. The company uses an algorithm to help match users to ideal products. It's emerged as a leader using its online-only strategy and its Il Makiage and Spoiled Child brands are gaining in popularity. On the earnings front, ODD's first-quarter fiscal 2025 report showed a 27% revenue increase, to $268 million. Adjusted EBITDA margin was almost at 20%, reflecting a reading of $52 million. The company's lack of debt and cash position of $257 million position it well for the future, as does its guidance. For the full year, ODD raised its gross margin outlook to 71%, adjusted EBITDA to an upward end of $161 million, and adjusted per-share earnings outlook to a high of $2.04. It's no wonder ODD shares are up 83% this year – and they could rise more. MoneyFlows data shows how Big Money investors are betting heavily on the forward picture of the stock. Institutional volumes reveal plenty. In the last year, ODD has enjoyed strong investor demand, which we believe to be institutional support. Each green bar signals unusually large volumes in ODD shares. They reflect our proprietary inflow signal, pushing the stock higher: Plenty of staples names are under accumulation right now. But there's a powerful fundamental story happening with Oddity. Institutional support and a healthy fundamental backdrop make this company worth investigating. As you can see, ODD has had strong sales and earnings growth: 3-year sales growth rate (+43.3%) 3-year EPS growth rate (+98.6%) Source: FactSet Also, EPS is estimated to ramp higher this year by +18.8%. Now it makes sense why the stock has been powering to new heights. ODD has a track record of strong financial performance. Marrying great fundamentals with our proprietary software has found some big winning stocks over the long term. Oddity has been a top-rated stock at MoneyFlows. That means the stock has unusual buy pressure and growing fundamentals. We have a ranking process that showcases stocks like this on a weekly basis. It's made the rare Outlier 20 report multiple times. The blue bars below show when ODD was a top pick…supported by Big Money inflows: Tracking unusual volumes reveals the power of money flows. This is a trait that most outlier stocks exhibit…the best of the best. Big Money demand drives stocks upward. The ODD rally isn't new at all. Big Money buying in the shares is signaling to take notice. Given the historical gains in share price and strong fundamentals, this stock could be worth a spot in a diversified portfolio. Disclosure: the author holds no position in ODD at the time of publication. If you are a Registered Investment Advisor (RIA) or are a serious investor, take your investing to the next level and follow our free weekly MoneyFlows insights. This article was originally posted on FX Empire Portugal: Persistent Political Fragmentation to Test Growth and Fiscal Prospects US Foods Seeing Inflows Market Outlook: Crypto Trading Big Money Buys LPL Financial Shares Should You Invest in European Stocks Now? Big Money Keeps Buying Palantir
Yahoo
16-05-2025
- Business
- Yahoo
Conneaut pursuing comprehensive zoning reform
CONNEAUT — The city is looking to conduct a comprehensive zoning reform this year, City Manager Nick Sanford said. He said the city identified the need for zoning reform in an update to its comprehensive plan in 2018. 'Our zoning text by and large dates back in 1982,' Sanford said. The city needs to update its zoning codes to reflect the fact it is not 1982 anymore, he said. 'Our zoning code's just old, frankly,' he said. City leadership is interested in reforms that work out for both residents and developers, Sanford said. Sanford is interested in having the zoning districts have more flexibility for development and applications for development, while working to preserve historic buildings in the city, he said. Sanford said the update has to focus on the fact Conneaut is geographically diverse, with a coastline and rural and urban areas. 'It's imperative that we are mindful of that,' he said. Sanford was thankful for the work of previous city administrations and councils for what they could do to pursue the issue, despite the COVID-19 pandemic, he said. Sanford is interested in having the zoning reforms done by the end of the year, he said. 'I think it's an achievable goal,' he said. The city is still in the early stages of the project, Sanford said. 'We're essentially testing waters to get started in this,' he said. Sanford said he wants to have community workshops to hear from residents. None are planned yet, he said. The city was interested in getting a grant from the Ohio Department of Development to fund the project. Council passed a resolution approving the grant application at an April 28 meeting. Sanford said ODD received around $2 million in requests, and had to close the window for funding applications early. 'This is something we're still going to pursue without funding,' he said. Sanford said MS Consultants, an engineering firm the city uses, has several employees versed in the nuances of zoning reform and law, who can help the city.
Yahoo
14-05-2025
- General
- Yahoo
Woman Says She's Naming Baby After Late Grandma, Even Though Her Sister Also Wants to Use the Name
A woman is fighting with her sister after naming her child after their late grandmother — a name the sister also wanted to use for a future child In a post shared to Reddit, the woman writes that she was closer with the grandmother than the sister was, even living with the woman in her childhood But the sister is now so upset she's brought their parents into the mixA woman says she's not sure what to do after her sister became "furious" that she named her daughter after their late grandmother — because the sister wanted to use the name, too. In a post shared on Reddit, the anonymous, 30-year-old woman writes that she and her sister are "not very close," and that the two lived apart during their childhood. "I lived with my grandma because my sister had ODD (oppositional defiant disorder) and a conduct disorder," the woman writes, adding, "I bonded deeply with grandma in the years I lived with her and I didn't want to go home when I did." She continues: "But my sister was stable enough by then for me to live with her and my parents again. Our relationship never got better from that point. We learned to be civil but there's no love lost between us." There were some tensions, the woman writes, when her grandmother died because she left her "a few special treasures" but left none to her sister. While the two had a falling out, they kept in touch sporadically and, when the poster found out she was pregnant, she told her family she had decided to name the child after her grandmother. "My sister told me I couldn't use grandma's name because she wanted to use it for a future daughter. She told me I didn't get to have the name," the woman writes. "Someone else said that nobody could claim a name and there was no reason we both couldn't use it." The woman then gave birth and did use the name, and her sister is now "furious." Their parents, meanwhile, are siding with the sister, "asking why I didn't just find a different name and let her use it." "They said after all she's been through and the stuff with inheritance I should be more understanding," she writes of her parents. "It annoyed me. My husband couldn't believe my parents would side with my sister on this." Never miss a story — sign up for to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories. Hundreds of people have weighed in on the post, with many saying the woman did "nothing wrong." "There is nothing you can do to prevent her from getting annoyed with you, and would find fault with anything you do. You did nothing wrong," writes one. Added another commenter: "Your daughter's name is a beautiful tribute to your beloved grandmother and your sister's behavior is just plain childish. Don't let her petty jealousy and entitlement ruin such a special moment for you and your family." Read the original article on People
Business Wire
14-05-2025
- Business
- Business Wire
IPS HEART Granted Orphan Drug Designation in the EU for Becker Muscular Dystrophy
HOUSTON--(BUSINESS WIRE)-- IPS HEART has been awarded Orphan Drug Designation (ODD) in the EU by the EUROPEAN MEDICINES AGENCY for GIVI-MPCs unique ability to create new muscle with 100% full length dystrophin in Becker Muscular Dystrophy (BMD). IPS HEART has now shown GIVI-MPCs can create new human muscle with full length human dystrophin in BMD dystrophic pigs, young and extremely aged Duchenne Muscular Dystrophy (DMD) mice and in a sarcopenia mouse model. The FDA previously awarded GIVI-MPCs Orphan Drug Designation for both BMD & DMD, highlighting the unique platform potential of GIVI-MPCs to reverse both devastating diseases. All current DMD therapeutics initially approved by the FDA through novel biomarkers including exon skipping and gene therapy therapeutics cannot produce 100% full length dystrophin nor can they create any new muscle to replace dead dystrophic muscle. While we are grateful to the dozens of BMD patients who have emailed us directly for information on our upcoming clinical trials, to date we are initially focused on advancing GIVI-MPCs clinically in a Phase I/II DMD clinical trial until we can secure additional partners to help us advance clinically in BMD. IPS HEART is currently under formal CDA with certain large pharmaceutical companies for a possible partnership that will also allow us to advance GIVI-MPCs clinically in BMD as we have already successfully produced GIVI-MPCs via large scale suspension based bioreactor manufacturing which can supply the large patient population in the future. About IPS HEART/GIVI-MPCs GIVI-MPCs derived from pluripotent stem cells form new skeletal muscle with 100% full-length human dystrophin for DMD and BMD. IPS HEART has also developed ISX-9-CPCs, a human iPSC-derived cardiac therapy for treatment of Duchenne cardiomyopathy and heart failure that develops new heart muscle. About Becker & Duchenne Muscular Dystrophy BMD is a muscular disease and DMD is a fatal neuromuscular disease.
